The present invention relates to suture devices, and more particularly, to a finger-guided suture device for placing sutures especially in body locations of limited minimal-invasive accessibility. The present invention further relates to surgical procedures in which one or more finger-guided suture devices of the present invention are used to place one or more sutures, especially in body locations of limited minimal-invasive accessibility.
For years, there has been a discernible, clear tendency in surgery and invasive diagnosis, especially, but not exclusively, in abdominal, joint, vaginal, in-utero and brain, surgeries or diagnoses, to develop procedures that would reduce the need for major access-providing incisions with their concomitant requirements of general anesthesia, extended hospitalization and increased infection hazard. One step in this direction was the introduction of endoscopy and laparoscopy, which, through provision of minimal incision in, e.g., the abdominal wall of joint covering skin, permits the introduction into the abdominal cavity or joint of a miniature television camera including a light source, as well as of various surgical instruments, including suture devices.
PCT/US97/11494 teaches a number of surgical instruments which can be mounted directly on a surgeon""s fingertip in a way that the surgeon can insert his or her hand into a natural cavity of the patient or through a minimal incision to perform surgical procedures, and also to use his or her fingers to manipulate tissues, thus enabling the surgeon to perform the procedures with the benefits of minimally invasive surgery, but with much greater tactile sense, control, and ease of manipulation. However, these surgical instruments (i) are carried by a finger and operated by the thumb, thereby are not applicable for procedures in which a single finger is employed for tactile sensing an operated intrabody location; (ii) include an operating head which permanently extends far beyond the fingertip on which the surgical instrument is mounted, which limits the tactile sensing of the surgeon; and/or (iii) prevent tactile sensing by the instrument carrying fingertip altogether.
According to the teachings of PCT/US97/11494 suturing can be performed while the surgeon uses tactile information collected by a single fingertip for tactile sensing the intrabody site to be stitched prior to the actual suturing. Several non-limiting examples of such suturing procedures are described in detail in the sections that follow. However, once the surgeon has collected the tactile information, surgery is conducted blindly within the body of the patient. According to the teachings of PCT/US97/11494, both the hands of the surgeon are engaged. Evidently, blindly operating surgical instruments intrabodily based on finger tip tactile information collected earlier may prove inconvenient, inaccurate and may increase the chance of inadvertently harming the patient.
PCT/IL99/00084 teaches design of finger-guided suture devices which can be used to perform extra- as well as intrabody suturing of tissue. This application does not teach construction and use of a device which causes a needle to penetrate a bodily tissue engage a piece of suture material and pull the suture material through the bodily tissue as the needle is retracted there through. In addition, this application fails to teach a construction which allows safe withdrawal of the needle in case of early detected misplacement other than pulling it via the hand or suture.
There is thus a widely recognized need for, and it would be highly advantageous to have, finger-guided suture devices devoid of the limitations associated with the prior art instruments and which enable a surgeon using a finger-guided surgical device to penetrate a bodily tissue with a suture needle, engage a piece of suture material with the needle and pull the suture material through the bodily tissue as the needle is retracted there through.
According to one aspect of the present invention there is provided a finger-guided suture device. The device comprises (a) a thimble-like element being adapted to surround a portion of a surgeon""s finger; (b) a rotatably mounted substantially semi-circular surgical needle within a housing formed within, or connected to, a wall of the thimble-like element, the surgical needle being designed for collecting the surgical suture via a distal portion of the surgical needle upon contact therewith and for retaining and guiding the surgical suture while suturing; and (c) a mechanism for imparting to said surgical needle a rotary movement in one direction for ejecting the surgical needle from the thimble-like element and thereafter a rotary movement in the opposite direction for withdrawing the surgical needle into the thimble-like element, so as to place a suture.
According to another aspect of the present invention there is provided a surgical procedure for bladder-neck suspension for treatment of urinary incontinence, the procedure comprising the step of suspending a pelvic fascia and a vaginal wall lateral to a urethra of a patient to Cooper""s ligament by a surgical suture applied by using a finger-guided suture device having a rotatably-driven substantially semi-circular surgical needle designed for collecting the surgical suture via a distal portion of the surgical needle upon contact therewith and for retaining and guiding the surgical suture while suturing.
According to yet another aspect of the present invention there is provided a surgical procedure for treatment of rectal prolapse, the procedure comprising the step of constricting an anal opening by a surgical suture applied by using a finger-guided suture device having a rotatably-driven, substantially semi-circular surgical needle designed for collecting the surgical suture via a distal portion of the surgical needle upon contact therewith and for retaining and guiding the surgical suture while suturing.
According to still another aspect of the present invention there is provided a surgical procedure for treatment of esophageal reflux, the procedure comprising the step of positioning a vessel loop around a esophagus of a patient by a surgical suture applied by using a finger-guided suture device having a rotatably-driven, substantially semi-circular surgical needle designed for collecting the surgical suture via a distal portion of the surgical needle upon contact therewith and for retaining and guiding the surgical suture while suturing.
According to an additional aspect of the present invention there is provided a surgical procedure for treatment of vaginal prolapse, the procedure comprising the step of tying an upper part of a vagina of a patient to a sacrospinous ligament of the patient by a surgical suture applied by using a finger-guided suture device having rotatably-driven, substantially semi-circular surgical needle designed for collecting the surgical suture via a distal portion of the surgical needle upon contact therewith and for retaining and guiding the surgical suture while suturing.
According to yet additional aspect of the present invention there is provided a surgical procedure for treatment of rupture of a rectum in large animals, the procedure comprising the step of suturing the rupture by a surgical suture applied by using a finger-guided suture device having a rotatably-driven, substantially semi-circular surgical needle designed for collecting the surgical suture via a distal portion of the surgical needle upon contact therewith and for retaining and guiding the surgical suture while suturing.
According to still additional aspect of the present invention there is provided a surgical procedure for treatment of rupture of a cervix in large animals, the procedure comprising the step of suturing the rupture by a surgical suture applied by using a finger-guided suture device having a rotatably-driven, substantially semi-circular surgical needle designed for collecting the surgical suture via a distal portion of the surgical needle upon contact therewith and for retaining and guiding the surgical suture while suturing.
According to still additional aspect of the present invention there is provided a surgical procedure for treatment of rupture of a uterus in large animals, the procedure comprising the step of suturing the rupture by a surgical suture applied by using a finger-guided suture device having a rotatably-driven, substantially semi-circular surgical needle designed for collecting the surgical suture via a distal portion of the surgical needle upon contact therewith and for retaining and guiding the surgical suture while suturing.
According to further features in preferred embodiments of the invention described below, the thimble like element is designed and constructed to expose the ventral tactile portions of the distal phalanx of the surgeon""s finger, so as to enable the surgeon to tactile sense a body location to be sutured.
According to still further features in the described preferred embodiments, the finger-guided suture device further comprises a cartridge for holding the surgical suture and presenting it for collection by the distal portion of the surgical needle.
According to still further features in the described preferred embodiments the cartridge includes at least one mechanism designed and constructed, so as to maintain a predetermined tension of the surgical suture.
According to still further features in the described preferred embodiments the at least one mechanism designed and constructed, so as to maintain a predetermined tension of the surgical suture comprises at least one piece of flexible material containing at least one hole through which the surgical suture passes.
According to still further features in the described preferred embodiments the at least one piece of flexible material containing at least one hole is selected from the group consisting of a single piece of flexible material containing two holes and a pair of pieces of flexible material each containing one hole.
According to still further features in the described preferred embodiments the flexible material is selected from the group consisting of silicon, latex, rubber, fabric, and fabric with an eyelet.
According to still further features in the described preferred is embodiments the eyelet is constructed of material selected from the group consisting of silicon, latex, rubber and fabric.
According to still further features in the described preferred embodiments the mechanism for ejecting the surgical needle from, and withdrawing the surgical needle into, the thimble-like element, is selected from the group consisting of a belt actuated mechanism, a gear actuated mechanism and a combined gear and belt actuated mechanism.
According to still further features in the described preferred embodiments the surgical needle is formed with a feature selected from the group consisting of a notch, a hook, at least one arm, and an openable loop at the distal end thereof.
According to still further features in the described preferred embodiments the finger-guided suture device further comprises an adapter insertable between the thimble-like element and the surgeon""s finger, so as to adapt the suture device to fingers of different size.
According to still further features in the described preferred embodiments the mechanism includes a first portion engaged within the housing and which is in contact with the ejectable surgical needle and a second, remote, portion which is to extend out of the patient""s body and which is operable by a free hand of the surgeon so as to eject the surgical needle from the thimble-like element.
According to still further features in the described preferred embodiments the first portion of the mechanism comprises a rotatable wheel having an axle, the axle serves for engaging the surgical needle and imparting a rotational motion in at least one direction thereto, the surgical needle includes a mechanism for engaging the rotatable wheel and a locking piece for insuring that the surgical needle and the rotatable wheel remain engaged.
According to still further features in the described preferred embodiments the first portion of the mechanism comprises a rotatable wheel having a mechanism for engaging a drive arm and imparting a rotational motion in at least one direction thereto, the drive arm is designed and constructed engageable by the rotatable wheel and by the surgical needle and to impart a rotational motion of the rotatable wheel in at least one direction to the surgical needle, wherein the surgical needle further includes a mechanism for engaging the drive arm and a disk for ensuring that the surgical needle, the drive arm and the rotatable wheel remain engaged.
According to still further features in the described preferred embodiments the remote portion which is to extend out of the patient""s body and which is operable by a free hand of the surgeon so as to eject the surgical needle from the thimble-like element comprises: (i) a hand operable actuator designed and constructed to operate a drive mechanism; (ii) a drive housing for containing at least a portion of the drive mechanism; and (iii) at least a portion of the drive mechanism, the drive mechanism being for imparting a rotational motion in at least one direction to the surgical needle.
According to still further features in the described preferred embodiments the hand operable actuator of the remote portion comprises (1) a handle for engaging at least one finger of the free hand of the surgeon; (2) an extending piece containing a plurality of arcurate teeth and being movable through the drive housing; (3) a pressure sensitive spring; and (4) a brake handle, the brake handle operable in a first direction by the pressure sensitive spring and in a second direction by the at least one finger of the free hand of the surgeon.
According to still further features in the described preferred embodiments the drive mechanism comprises (1) a plurality of arcuate is teeth deployed in a linear arrangement along an extending piece of a handle; (2) a first gear with a first circular arrangement of arcuate teeth, the first circular arrangement of arcuate teeth being for engaging with the plurality of arcuate teeth deployed in the linear arrangement along the extending piece, such that linear displacement of the extending piece is translated into rotational motion of the first gear; (3) a second gear including a second circular arrangement of arcuate teeth, the arcuate teeth of the second gear being for engaging the first circular arrangement of arcuate teeth of the first gear, such that rotational motion of the first gear causes rotational motion of the second gear; and (4) a cable in contact with at least one point on the second gear, such that rotational motion of the second gear is translated to linear motion of at least a portion of the cable.
According to still further features in the described preferred embodiments the drive mechanism further comprises (5) a ratchet for alternately engaging and releasing at least one arcuate tooth of the first gear; (6) a ratchet control arm for alternately engaging and releasing the ratchet; (7) a brake handle for alternately operating the ratchet control arm. These components are arranged so that when the brake handle operates the ratchet control arm, the ratchet control arm releases the ratchet, the ratchet engages the at least one arcuate tooth of the first gear and the first gear is prevented from rotating. This means that when the brake handle does not operate the ratchet control arm, the ratchet control arm engages the ratchet, the ratchet releases the at least one arcuate tooth of the first gear and the first gear is free to rotate.
According to still further features in the described preferred embodiments the thimble-like element is constructed so as to be mounted over a dorsal side of the distal phalanx of the surgeon""s finger, thereby exposing the entire ventral tactile portions of the distal phalanx.
According to still further features in the described preferred embodiments the thimble-like element is constructed so as to fully surround the distal phalanx and expose the tip of the ventral tactile portion of the distal phalanx.
According to still further features in the described preferred embodiments the thimble-like element is constructed so as to be mounted over a ventral side of the distal phalanx of the surgeon""s finger and expose the tip of the ventral tactile portion of the distal phalanx.
According to still further features in the described preferred embodiments the surgical needle is ejectable in a direction generally perpendicular to a longitudinal axis of the thimble like element.
According to still further features in the described preferred embodiments the surgical needle travels along at least a portion of a circular path, the path being on a plane which substantially parallels a plane traversing the surgeon""s finger from top to bottom.
According to still further features in the described preferred embodiments the surgical needle travels along at least a portion of a circular path, the path being on a plane which substantially parallels a plane traversing the surgeon""s finger from side to side.
According to still further features in the described preferred embodiments the surgical needle travels along at least a portion of a circular path, the path being on a plane which is substantially perpendicular to the longitudinal axis of the surgeon""s finger.
According to still further features in the described preferred embodiments the finger-guided suture device further comprises an optical head engaged by the thimble like element.
According to still further features in the described preferred embodiments the finger-guided suture device further comprises the surgical suture formed with a loop for collection by the surgical needle.
According to still further features in the described preferred embodiments the wall is a side wall of the thimble-like element.
According to still further features in the described preferred embodiments the wall is a front wall of the thimble-like element.
According to still further features in the described preferred embodiments the finger-guided suture device further comprises a reporting mechanism for reporting at least one situation selected from the group consisting of a full ejection of the substantially semi-circular surgical needle, a full withdrawal of the substantially semi-circular surgical needle, a degree of ejection of the substantially semi-circular surgical needle and a degree of withdrawal of the substantially semi-circular surgical needle.
The present invention successfully addresses the shortcomings of the presently known configurations by providing a finger guided suture including a needle which is capable of collecting the surgical suture via a distal portion of the surgical needle upon contact therewith and retaining and guiding the surgical suture while suturing.